PMID- 23668924
OWN - NLM
STAT- MEDLINE
DCOM- 20140204
LR  - 20181202
IS  - 1878-5506 (Electronic)
IS  - 1389-9457 (Linking)
VI  - 14
IP  - 6
DP  - 2013 Jun
TI  - Effectiveness and tolerability of rotigotine transdermal patch for the treatment 
      of restless legs syndrome in a routine clinical practice setting in Germany.
PG  - 475-81
LID - S1389-9457(13)00106-8 [pii]
LID - 10.1016/j.sleep.2013.02.013 [doi]
AB  - OBJECTIVE: We aimed to assess effectiveness and tolerability of rotigotine in 
      patients with moderate to severe idiopathic restless legs syndrome (RLS) under 
      daily practice conditions in Germany. METHODS: In this 3-month noninterventional 
      study, effectiveness was assessed using RLS-6 (primary variables were symptom 
      severity when falling asleep [item 2] and during the night [item 3]). Data were 
      collected at baseline and at the end of treatment. Safety assessments included 
      adverse events (AEs). RESULTS: Six hundred and eighty-four patients were treated 
      with rotigotine and 418 (61%) completed the study. The full analysis set (FAS) 
      comprised 564 patients (106 de novo; 458 pretreated [454 had complete rotigotine 
      dosing data]). Mean rotigotine dose of longest duration was 2.4+/-1.4 mg/24 h. 
      Rotigotine improved all RLS-6 items (mean change from baseline [item 2], 
      -2.4+/-3.6; [item 3], -2.7+/-3.4), with the most pronounced improvement observed in 
      daytime symptoms while at rest (item 4, -2.9+/-3.2). AEs were typical of 
      dopaminergic treatment and transdermal administration. De novo patients generally 
      started rotigotine on 1 mg/24 h (85% [90/106]) and pretreated patients on 1 (50% 
      [227/454]) or 2 mg/24 h (40% [183/454]). Most patients who were pretreated with 
      levodopa (57%), pramipexole (84%), or ropinirole (78%) monotherapy discontinued 
      these medications on initiation of rotigotine. CONCLUSIONS: Rotigotine was 
      effective and well-tolerated when used in routine clinical practice.
CI  - Copyright (c) 2013 Elsevier B.V. All rights reserved.
FAU - Stiasny-Kolster, Karin
AU  - Stiasny-Kolster K
AD  - Somnomar, Institute for Medical Research and Sleep Medicine, Marburger Str. 9a, 
      Marburg 35043, Germany. stiasny-kolster@somnomar.de
FAU - Berg, Daniela
AU  - Berg D
FAU - Hofmann, Werner E
AU  - Hofmann WE
FAU - Berkels, Reinhard
AU  - Berkels R
FAU - Grieger, Frank
AU  - Grieger F
FAU - Lauterbach, Thomas
AU  - Lauterbach T
FAU - Schollmayer, Erwin
AU  - Schollmayer E
FAU - Bachmann, Cornelius G
AU  - Bachmann CG
LA  - eng
SI  - ClinicalTrials.gov/NCT01113710
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130511
PL  - Netherlands
TA  - Sleep Med
JT  - Sleep medicine
JID - 100898759
RN  - 0 (Benzothiazoles)
RN  - 0 (Dopamine Agonists)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 46627O600J (Levodopa)
RN  - 83619PEU5T (Pramipexole)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
MH  - Aged
MH  - Benzothiazoles/administration & dosage/adverse effects
MH  - Dopamine Agonists/*administration & dosage/adverse effects
MH  - Female
MH  - Germany
MH  - Humans
MH  - Levodopa/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pramipexole
MH  - Restless Legs Syndrome/*drug therapy
MH  - Self Administration
MH  - Tetrahydronaphthalenes/*administration & dosage/adverse effects
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Transdermal Patch
MH  - Treatment Outcome
EDAT- 2013/05/15 06:00
MHDA- 2014/02/05 06:00
CRDT- 2013/05/15 06:00
PHST- 2012/11/30 00:00 [received]
PHST- 2013/02/27 00:00 [revised]
PHST- 2013/02/28 00:00 [accepted]
PHST- 2013/05/15 06:00 [entrez]
PHST- 2013/05/15 06:00 [pubmed]
PHST- 2014/02/05 06:00 [medline]
AID - S1389-9457(13)00106-8 [pii]
AID - 10.1016/j.sleep.2013.02.013 [doi]
PST - ppublish
SO  - Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 
      11.